pharmacovigilance set up poster

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this is just an example. any resemblance to any comapny n product is just conincidence. we have prepared it for college project as an advertisement.

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  • C & C research
  • pharmacovigilance set up poster

    1. 1. Proposal for setting up of pharmacovigilance center Cure & Care Research Pharmacovigilance Aim of pharmacovigilance center Cure and care research offers comprehensive pharmacovigilance services to pharmaceuticals, biotechnology and medical device company across the product life cycle. Our pharmacovigilance team consists of healthcare professionals with wide clinical as well as drug safety experience spanning multiple therapeutic areas. The dedicated team of pharmacovigilance associates, scientists and physicians experts in recognizing, processing, analyzing and reporting AEs. Major aims of pharmacovigilance are: 1. Early detection of hitherto unknown adverse reactions and interactions 2. Detection of increases in frequency of (known) adverse reactions 3. Identification of risk factors and possible mechanisms underlying adverse reactions 4. Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve drug prescribing and regulation Cure and care research advantage <ul><li>expertise that cover both pre and post marketing pharmacovigilance </li></ul><ul><li>comprehensive SOPs, Quality management systems and compliance measures maintain the pharmacovigilance system audit and inspection ready </li></ul><ul><li>significant reduction of costs for the client that can be allocated to their R&D </li></ul><ul><li>Electronic Adverse reporting capabilities </li></ul><ul><li>Application of good pharmacovigilance practices and integration of new regulatory and technical developments to the system </li></ul>Services <ul><li>  </li></ul><ul><li>our pharmacovigilance experts specialized in the management of both clinical trial and post-marketing AE's and offer complete support from case creation to submission. we process cases in either the client's database or our database. </li></ul><ul><li>CASE CREATION AND TRAIGE </li></ul><ul><li>24/7 call centre support for collecting adverse event reports from clinical trial and post-marketing sources </li></ul><ul><li>Triage of cases based on seriousness and expectedness </li></ul><ul><li>CASE PROCESSING </li></ul><ul><li>Entry of adverse event data </li></ul><ul><li>Active query and follow-up of cases </li></ul><ul><li>MedRA coding </li></ul><ul><li>safety narrative writing and quality check of case reports for data completeness </li></ul><ul><li>MEDICAL REVIEW </li></ul><ul><li>Qualified physician review of the cases for completeness, accurateness and capture of all medical concepts </li></ul><ul><li>Medical assessment/casuality assessment </li></ul><ul><li>Signal detection and Benefit-Risk analysis </li></ul><ul><li>SUBMISSION </li></ul><ul><li>Adverse events tracking and routing </li></ul><ul><li>Expedited reports submission to regulatory authorities </li></ul><ul><li>Regulatory reporting to authorities, investigators and ethics committees </li></ul>Our mission Process MAP <ul><li>PERIODIC REPORTS </li></ul><ul><ul><li>Annual safety reports </li></ul></ul><ul><ul><li>IND Annual reports </li></ul></ul><ul><ul><li>Periodic safety update reports </li></ul></ul><ul><ul><li>Addendum reports </li></ul></ul><ul><ul><li>Bridging reports </li></ul></ul><ul><ul><li>US Periodic reports </li></ul></ul><ul><li>LITERATURE SEARCH </li></ul><ul><ul><li>Running searches for literature </li></ul></ul><ul><ul><li>Products from online bibliographic databases </li></ul></ul><ul><ul><li>Entry of identified cases into the safety database </li></ul></ul><ul><ul><li>Literature searches for the purpose of inclusion </li></ul></ul><ul><ul><li>Evaluation of safety issues and signals in PSUR. </li></ul></ul><ul><li>TRAINING SERVICES </li></ul><ul><ul><li>Short-term training programmes in • Pharmacovigilance </li></ul></ul><ul><ul><li>Certificate course in Pharmacovigilance </li></ul></ul>Location Contact information Cure & Care Research Abu building, New delhi – 110009. Telephone: 011983452 Toll free number: +91045868776 E-mail:service@cure&careresearch.com Web site: www.cnc.com Future Strategies and proposals <ul><li>Building and strengthening a robust PV system </li></ul><ul><li>Mandatory reporting and introducing PV inspections </li></ul><ul><li>High level discussions with various stakeholders </li></ul><ul><li>Strengthen the DCGI office with trained scientific and medical assessors for pharmacovigilance </li></ul><ul><li>Creating a single country-specific adverse event reporting form to be used by all </li></ul><ul><li>Creating a clinical trial and post-marketing database for SAEs/SUSARs and ADRs </li></ul><ul><li>List all new drugs/ indications by maintaining a standard database for every pharmaceutical company </li></ul><ul><li>Training programs - HCP, medical students, nursing and pharmacy graduates, workers in rural areas </li></ul><ul><li>A uniform format for data collection and reporting needs to be designed </li></ul><ul><li>Active participation from industry, both domestic and multinational, in the drug safety monitoring during clinical trials and post marketing must be ensured. </li></ul><ul><li>collaborating with pharmacovigilance organizations in enhancing drug safety </li></ul><ul><li>Building a network of pharmacovigilance and Pharmacoepidemiologists in India </li></ul><ul><li>A National Database </li></ul>We are there for you… Human resources : Ms. Mahi Gautam :+91 9900011111 Services : Mr. Jatin Chug : +919911110000 For any other query : Mr. Dinesh Bhatia : +919800012213 C&C

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